Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients

Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients: Randomized Clinical Trial

This study will be conducted to evaluate the effect of Propolis-containing toothpaste in comparison to Fluoride-containing Toothpaste by caries risk assessment in high caries risk patients.

Study Overview

• Status: Unknown
• Conditions: Risk Reduction
• Intervention / Treatment: Drug: propolis-containing toothpaste; Drug: Fluoride-containing toothpaste

Detailed Description

A total of 40 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of Toothpaste (A) where group A1 patients will use propolis containing toothpaste twice daily while group A2 patients will use fluoride containing toothpaste twice daily as control with 20 patients in each group. Each group will be further divided into three groups according to caries risk assessment times (T) where T0 represents caries risk assessment of patients before application of propolis and fluoride toothpastes and T1 represents caries risk assessment of patients after three months of application of propolis and fluoride toothpastes, T2 represents caries risk assessment of patients after six months of application of propolis and fluoride toothpastes.

Both Propolis containing toothpaste and fluoride containing toothpaste will be placed in concealed tubes. The tubes will completely wrapped by plain white tape to conceal the formulation of toothpaste. Participants are given the tubes of toothpaste and soft brush with a coloured mark at 2 cm length of the bristle surface. The technique can be summarised in four steps:

1. 2 cm of the toothpaste will be squeezed over the wet toothbrush bristles
2. The upper and lower teeth will be brushed for 2 min;
3. After brushing, the remaining toothpaste foam and saliva "slurry" will be swished around the dentition with active movements of the cheeks, lips and tongue, forcing the slurry in between the teeth for about 20 seconds before expectorating the slurry
4. No post-brushing water rinsing will be carried out All these steps will be presented in a reminder card and all patients will put a tick mark for every step.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants should be over 18 years of age.
• Participants should be high caries risk.
• Systematically healthy.
• Not taking any medication interfering with saliva secretion.
• Participants who signed informed consent.

Exclusion criteria:

• Participants with a compromised medical history.
• Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
• Severe or active periodontal disease.
• History of allergies or other adverse reactions to propolis, or oral care product or their ingredient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propolis-containing toothpaste; Assessment of caries risk for participants using Propolis-containing toothpaste before the treatment , after 3 months and 6 months follow up.	Drug: propolis-containing toothpaste; participants will use propolis-containing toothpaste for 6 months; Other Names: Red seal propolis toothpaste
Experimental: Fluoride-containing toothpaste; Assessment of caries risk for participants using Fluoride-containing toothpaste before the treatment , after 3 months and 6 months follow up.	Drug: Fluoride-containing toothpaste; participants will use Fluoride-containing toothpaste for 6 months; Other Names: colgate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving caries risk	caries risk assessment	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Fluorides; Propolis
• Other Study ID Numbers: CEBC-CU-2017-07-26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No